Recall Z-1723-2019 ยท PYC Paracentesis Tray
Cook Inc.
Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284
| Date | Apr 9, 2019 |
| Status | Terminated |
| Reason | Affected products may have been manufactured with the catheter distal end hole too small |
| Action | On April 9, 2019 Cook Medical issued URGENT MEDICAL DEVICE RECALL notices to customers via courier service. Customers were advised to take the following Actions: 1. Examine your inventory immediately to determine if you have affected product(s), and quarantine affected product(s). Immediately cease all distribution and use of these products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. NOTE: Unaffected products that are returned will not be credited. 3. Complete and return the Acknowledgement and Receip |
| Quantity | 2 kits |
| Distribution | Domestically: OH; Internationally: CANADA, SPAIN, ITALY, BELGIUM, GERMANY, UNITED ARAB EMIRATES, GREECE, SWITZERLAND, OMAN, MONACO, SAUDI ARABIA, AUSTRALIA, HONG KONG, INDIA & KOREA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.